#China #Shanghai #ArkBio #Azstarys #ADHD treatment

ArkBio's Azstarys Drug Application for ADHD Approved

Introduction

In a significant development in ADHD treatment, Shanghai Ark Biopharmaceutical Co., Ltd. announced that its New Drug Application (NDA) for Azstarys has been accepted by the National Medical Products Administration (NMPA) of China. What makes this approval particularly noteworthy is that Azstarys is granted Priority Review status, aiming to expedite the availability of this promising therapeutic for Attention-Deficit/Hyperactivity Disorder (ADHD) patients aged six and above.

A New Approach to ADHD Medication

Azstarys, which features a combination of dexmethylphenidate (d-MPH) and the prodrug serdexmethylphenidate (SDX), stands out as the first-ever methylphenidate combination therapeutic approved globally. The unique formulation not only delivers rapid onset of action but also ensures sustained symptom control, offering a dual-phase release that enhances patient outcomes.

Azstarys is recognized for setting a new standard in ADHD management through its innovative design, which offers the potential for improved safety and efficacy compared to traditional ADHD medications.

How Azstarys Works

The pharmacokinetic properties of Azstarys allow it to provide:
1. Rapid Onset: The immediate-release component of d-MPH ensures that patients experience relief from core ADHD symptoms within 30 minutes of ingestion.
2. Extended Control: Once ingested, SDX is metabolized slowly into d-MPH, thus providing therapeutic effects for up to 13 hours. This continuous release minimizes the risk of evening rebound symptoms, a common issue faced by patients at the end of the day.
3. Stable Release Profile: Designed to support patients throughout their daily activities—from school to evening routines—Azstarys enhances adherence to treatment by minimizing disruptions to sleep patterns, catering to both pediatric and adult needs.

Abuse-Deterrent Features

In an era of growing concerns around medication misuse, Azstarys boasts an abuse-deterrent design. The formulation is designed such that the conversion of SDX occurs slowly in the gastrointestinal tract, limiting the peak plasma concentrations of d-MPH. Consequently, this design significantly reduces the likelihood of non-oral misuse, which is a crucial public health consideration in ADHD treatment.

Clinical Trials and Efficacy

The acceptance of Azstarys' NDA followed promising results from a Phase III clinical trial conducted across eight major hospitals in China. This multicenter trial demonstrated statistically significant improvements in both primary and secondary efficacy endpoints compared to placebo, reinforcing the drug's potential as a safe and effective treatment option.
The trial reported no serious adverse events directly related to the drug, underscoring Azstarys' favorable safety profile and its suitability for long-term use, particularly in pediatric patients.

Transforming ADHD Treatment in China

If approved, Azstarys will become the first combination ADHD medication available in the Chinese market, effectively transforming the existing paradigm of ADHD treatment. The drug promises to offer better options for patients, their families, and healthcare professionals by combining rapid symptom relief with extended management of ADHD throughout the day.

Conclusion

Dr. Jim Wu, CEO of ArkBio, highlighted the significance of this development, stating, "The acceptance of Azstarys' NDA and its Priority Review designation reflect favorable opinions regarding our scientific data and clinical outcomes. ADHD remains critically underserved in China, and Azstarys is designed to meet the urgent needs of patients efficiently."

This milestone not only signals a potential shift in ADHD treatment approaches in China but also reaffirms ArkBio’s commitment to developing innovative therapeutic solutions for challenging medical conditions.

For more information about ArkBio and its innovative approaches to pharmaceuticals, visit their official website.